(23 days)
The Encore 26 Advantage Kit is a kit of sterile disposable devices intended of ruse as accessories for percutaneous coronary angiography (PTCA) procedures. They allow for balloon inflation and wire control.
Encore™ 26 Inflation Device: indicated for use with balloon dilatation catheters to create and monitor pressure in the balloon, and to deflate the balloon.
Gateway™ Plus Y-Adaptor: used for providing hemostasis around balloon dilatation catheters, guidewires and other therapeutic devices during general intravascular procedures.
Torque Device: used for guidewire manipulation during general intravascular procedures.
Insertion Tool: used to facilitate the introduction of a quidewire during general intravascular procedures.
The Encore™ 26 Advantage Kit is a Kit of sterile disposable devices intended for use as accessories and percutaneous coronary angiography (PTCA) procedures. They allow for balloon inflation and wire control.
This is a 510(k) premarket notification for a medical device (Encore™ 26 Advantage Kit), which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a clinical study with acceptance criteria and performance metrics in the way one might for a novel AI algorithm or diagnostic tool.
Therefore, many of the requested sections are not applicable to the provided document. I will fill in the information that is present or directly inferable from the document.
1. A table of acceptance criteria and the reported device performance
The submission states, "Design Verification and Design Validation Testing was performed to verify that the performance and usability of the modified Insertion Tool remains substantially equivalent to the predicate device via K140673. In addition Sterilization, Packaging and Biocompatibility testing verifies the overall substantial equivalence to the kit predicate."
While specific numerical acceptance criteria and performance values for each test are not listed in this summary document, the overall acceptance criterion is substantial equivalence to the predicate device(s). The reported performance is that the device met this criterion.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantial equivalence in performance to predicate device (K123214 and K922410) for the modified Insertion Tool | Design Verification and Design Validation Testing showed the modified Insertion Tool remains substantially equivalent to the predicate device. |
| Substantial equivalence in sterilization, packaging, and biocompatibility to the kit predicate | Sterilization, Packaging and Biocompatibility testing verifies overall substantial equivalence to the kit predicate. |
| No new safety or performance issues raised | No new safety or performance issues were raised during the device testing. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the summary. The document refers to "Design Verification and Design Validation Testing" but does not detail the specific sample sizes used for these engineering/performance tests. Data provenance (country of origin, retrospective/prospective) is not applicable or provided for this type of device submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This is not applicable to a device like a balloon inflation kit. Ground truth, in the context of diagnostic algorithms, involves expert labeling of data. For a hardware medical device, "ground truth" would relate to engineering specifications and performance benchmarks, not expert consensus on medical images or diagnoses.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods are typically used in clinical studies involving human interpretation or subjective assessments, not for performance testing of a mechanical device.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is not an AI-assisted diagnostic device, and no MRMC study was conducted or mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm-based device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For this type of device, the "ground truth" for performance testing would be established by:
- Engineering specifications and standards: Performance parameters (e.g., pressure capabilities, sealing integrity, material strength, dimensional accuracy) are measured against predefined engineering requirements and industry standards.
- Predicate device performance: The performance of the predicate device serves as the benchmark for substantial equivalence.
8. The sample size for the training set
Not applicable. This is not a machine learning or AI device that uses a "training set."
9. How the ground truth for the training set was established
Not applicable.
§ 870.1650 Angiographic injector and syringe.
(a)
Identification. An angiographic injector and syringe is a device that consists of a syringe and a high-pressure injector which are used to inject contrast material into the heart, great vessels, and coronary arteries to study the heart and vessels by x-ray photography.(b)
Classification. Class II (special controls). The device, when it is a non-patient contacting balloon inflation syringe intended only to inflate/deflate balloon catheters and monitor pressure within the balloon, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.